UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032856 |
|---|---|
| Receipt number | R000037467 |
| Scientific Title | Glycemic variability from switching to steady state in patients treated with long-acting insulin: randomised crossover study |
| Date of disclosure of the study information | 2018/06/04 |
| Last modified on | 2020/01/29 13:55:18 |
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Basic information
Public title
Glycemic variability from switching to steady state in patients treated with long-acting insulin: randomised crossover study
Acronym
Glycemic variability from switching to steady state in patients treated with long-acting insulin
Scientific Title
Glycemic variability from switching to steady state in patients treated with long-acting insulin: randomised crossover study
Scientific Title:Acronym
Glycemic variability from switching to steady state in patients treated with long-acting insulin
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the glycemic variability from switching to steady state in patients treated with long-acting insulin (insulin glargine 300 U/ml, next, insulin degludec or insulin degludec, next, insulin glargine 300 U/ml).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean of daily difference 1 (MODD1)
Key secondary outcomes
Multiple continuous overlapping net glycemic action 24 (MCONGA24) (original index)
Standard deviation of daily difference (SDODD) (original index)
Mean of daily difference (MODD) (day before switching vs. first day, second day vs. third day, fifth day vs. sixth day)
continuous overlapping net glycemic action 24 (CONGA24) (day before switching vs. first day, second day vs. third day, fifth day vs. sixth day)
Mean absolute glucose (MAG) during evaluation duration (for 7 days)
Glycemic variability percentage (GVP) during evaluation duration (for 7 days)
Mean glucose level during evaluation duration (for 7 days)
Standard deviation (SD) during evaluation duration (for 7 days)
Coefficient of variation (CV) during evaluation duration (for 7 days)
We investigated the relationship between glycemic diurnal variation (MAG, GVP, mean glucose level, and SD) and glycemic daily variation (MODD and CONGA24) using simulated CGM profiles measured every 15 minute for 24 hours.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Upon admission, insulin glargine 300 U/ml is continued for 6 days with the same dose. FreeStyle Libre Pro is worn on fifth day of the same dose insulin glargine 300 U/ml. Insulin glargine 300 U/ml is switched to insulin degludec on day 3 of wearing CGM device with the same dose and is continued for 6 days. Then, Insulin degludec is switched to insulin glargine 300 U/ml on day 9 with the same dose and is continued for 6 days. Evaluation duration are from day 2 to day 8 and from day 8 to day 14.
Interventions/Control_2
Upon admission, insulin degludec is continued for 6 days with the same dose. FreeStyle Libre Pro is worn on fifth day of the same dose insulin degludec. Insulin degludec is switched to insulin glargine 300 U/ml on day 3 of wearing CGM device with the same dose and is continued for 6 days. Then, Insulin glargine 300 U/ml is switched to insulin degludec on day 9 with the same dose and is continued for 6 days. Evaluation duration are from day 2 to day 8 and from day 8 to day 14.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
type 2 diabetic patients treated with long-acting insulin in basal insulin therapy for 3 month or longer
Key exclusion criteria
severe renal dysfunction (serum creatinine level over 2.0 mg/dL)
judged to be unsuitable for participation for medical reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
Inuyama Chuo General Hospital
Division name
Diabetes
Zip code
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL
0568-62-8111
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
Inuyama Chuo General Hospital
Division name
Diabetes
Zip code
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL
0568-62-8111
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
Inuyama Chuo General Hospital
Institute
Department
Personal name
Funding Source
Organization
Inuyama Chuo General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037467
